Female breast augmentation, breast reconstruction, mammoplasty and breast orthopedics are widely used in patients with breast cancer after surgical resection and people in need of plasty. During the past 20 years, such surgery techniques have been improved greatly. The probability of complications occurring within a short period after the surgery has been significantly decreased. The breast prosthesis has achieved widespread application in breast augmentation and breast reconstruction. However, performing breast augmentation, breast reconstruction, mammoplasty and breast orthopedics by using breast prosthesis could still cause many serious problems during a longer period after the surgery. These problems include the sclerosis of fibrous (scar) tissue encapsulating the prosthesis and the breast distortion, resulting in undesirable aesthetic effects as well as the problems such as discomfort, mastosis and the like. The sclerosis and contraction of the capsule may rupture the aged breast prosthesis over time. Similar problems may occur in about one out of six patients implanted with breast prosthesis.
The fixation and support of the breast prosthesis mainly depend on autologous tissues of the patient. Due to the gravity of the breast prosthesis and the relaxation of the human tissue, the breast prosthesis may further prolapse or translocate over time and thereby directly affect the aesthetic effect. For patients with the breast resected, the difficulty for breast reconstruction increases due to the lack of support from autologous surrounding tissues of the patients. Autologous breast reconstruction is also referred to the operation of moving the skin, fat or muscle of other autologous regions to the breast of the patients. The tissue required by autologous reconstruction may be collected from abdomen, upper back, upper hip or hip. This type of surgery increases the complexity of surgery. It could introduce additional donor site wounds and damages during tissue collection and result in a longer recovery time and the formation of extra scars. In addition, autologous reconstruction is not suitable for overweighed and smoking patients, and patients with surgical history or circulatory system diseases in the tissue collection region. Furthermore, it is difficult for lean patients to use this method in breast reconstruction since there are insufficient soft tissues in abdomen and back.
Tissue matrices made from donated human cadaver tissues or from the properly processed animal tissues began to be utilized in recent few years in various surgical operations such as female breast augmentation, breast reconstruction, mammoplasty and breast orthopedics. Since these tissue materials are generally sheet-like or planar membranaceous materials, during the breast reconstruction surgery, surgeons need to tailor the materials into the shapes and sizes according to the situation of surgeries and implants used. The irregular shapes and sizes of the tissue matrices made by the surgeon during surgical operations often do not fit well to the selected breast prosthesis and the surgical region of a patient, resulting in less desirable plastic and cosmetic effect. For example, it is difficult to avoid folding or pleating, to manage the shape of the breast and to achieve a proper projection of the reconstructed breast. Meanwhile, since the materials are expensive and the operations are also error prone for the surgeons to tailor the materials into shapes on the spot via visual inspection when performing the surgeries, the materials could be wasted that increases the surgical costs.
Therefore, implantable tissue matrix devices for facilitating the fixation, support and coverage of the breast prosthesis in female breast augmentation, breast reconstruction, mammoplasty and breast orthopedics needs to be further developed and improved.